The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309457971
Category : Medical
Languages : en
Pages : 145

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Book Description
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309457971
Category : Medical
Languages : en
Pages : 145

Get Book Here

Book Description
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442354
Category : Medical
Languages : en
Pages : 135

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Book Description
Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030944232X
Category : Medical
Languages : en
Pages : 135

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Book Description
Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

Cancer Immunotherapy Principles and Practice

Cancer Immunotherapy Principles and Practice PDF Author: Lisa H. Butterfield
Publisher:
ISBN: 9781620700976
Category : Cancer
Languages : en
Pages : 0

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Book Description
Part 1: Intratumoral Signatures Associated With Immune Responsiveness

Progress in Cancer Immunotherapy

Progress in Cancer Immunotherapy PDF Author: Shuren Zhang
Publisher: Springer
ISBN: 9401775559
Category : Medical
Languages : en
Pages : 293

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Book Description
This book provides readers an extensive overview of recent progress in basic and clinical research on cancer immunotherapy. Thanks to rapid advances in molecular biology and immunology, it has become increasingly evident that cancer growth is influenced by host immune responses. With the success of a number of clinical trials, immunotherapy has become a promising treatment modality of cancer. This book covers five major topics, including monoclonal antibodies, biological response modifiers, cancer vaccines, adoptive cellular therapy and oncolytic viruses. It also examines the combination of different immune strategies as well as the combination of immunotherapy with other treatments to increase anti-tumor effects. Through the comprehensive discussion of the topic, the book sheds valuable new light on the treatment of tumors.

Cancer Vaccines and Immunotherapy

Cancer Vaccines and Immunotherapy PDF Author: Peter L. Stern
Publisher: Cambridge University Press
ISBN: 9780521622639
Category : Medical
Languages : en
Pages : 304

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Book Description
Rapid progress in the definition of tumor antigens, and improved immunization methods, bring effective cancer vaccines within reach. In this wide-ranging survey, leading clinicians and scientists review therapeutic cancer vaccine strategies against a variety of diseases and molecular targets. Intended for an interdisciplinary readership, their contributions cover the rationale, development, and implementation of vaccines in human cancer treatment, with specific reference to cancer of the cervix, breast, colon, bladder, and prostate, and to melanoma and lymphoma. They review target identification, delivery vectors and clinical trial design. The book begins and ends with lucid overviews from the editors, that discuss the most recent developments.

Immunotherapy of Hepatocellular Carcinoma

Immunotherapy of Hepatocellular Carcinoma PDF Author: Tim F. Greten
Publisher: Springer
ISBN: 9783319879116
Category : Medical
Languages : en
Pages : 0

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Book Description
In this book we provide insights into liver – cancer and immunology. Experts in the field provide an overview over fundamental immunological questions in liver cancer and tumorimmunology, which form the base for immune based approaches in HCC, which gain increasing interest in the community due to first promising results obtained in early clinical trials. Hepatocellular carcinoma (HCC) is the third most common cause of cancer related death in the United States. Treatment options are limited. Viral hepatitis is one of the major risk factors for HCC, which represents a typical “inflammation-induced” cancer. Immune-based treatment approaches have revolutionized oncology in recent years. Various treatment strategies have received FDA approval including dendritic cell vaccination, for prostate cancer as well as immune checkpoint inhibition targeting the CTLA4 or the PD1/PDL1 axis in melanoma, lung, and kidney cancer. Additionally, cell based therapies (adoptive T cell therapy, CAR T cells and TCR transduced T cells) have demonstrated significant efficacy in patients with B cell malignancies and melanoma. Immune checkpoint inhibitors in particular have generated enormous excitement across the entire field of oncology, providing a significant benefit to a minority of patients.

A New Deal for Cancer

A New Deal for Cancer PDF Author: Abbe R. Gluck
Publisher: PublicAffairs
ISBN: 1541700627
Category : Medical
Languages : en
Pages : 416

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Book Description
An unprecedented constellation of experts—leading cancer doctors, policymakers, cutting-edge researchers, national advocates, and more—explore the legacy and the shortcomings from the fifty-year war on cancer and look ahead to the future. The longest war in the modern era, longer than the Cold War, has been the war on cancer. Cancer is a complex, evasive enemy, and there was no quick victory in the fight against it. But the battle has been a monumental test of medical and scientific research and fundraising acumen, as well as a moral and ethical challenge to the entire system of medicine. In A New Deal for Cancer, some of today’s leading thinkers, activists, and medical visionaries describe the many successes in the long war and the ways in which our deeper failings as a society have held us back from a more complete success. Together they present an unrivaled and nearly complete map of the battlefield across dimensions of science, government, equity, business, the patient provider experience, and more, documenting our emerging understanding of cancer’s many unique dimensions and offering bold new plans to enable the American health care system to deliver progress and hope to all patients.

SITC’s Guide to Managing Immunotherapy Toxicity

SITC’s Guide to Managing Immunotherapy Toxicity PDF Author: Marc S. Ernstoff, MD
Publisher: Springer Publishing Company
ISBN: 0826172156
Category : Medical
Languages : en
Pages : 275

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Book Description
The Society for Immunotherapy of Cancer's handbook,SITC’s Guide to Managing Immunotherapy Toxicity, is a practical reference to managing side effects associated with FDA-approved cancer immunotherapy drugs. Separated into two parts, Part I contains chapter-based overviews of immune checkpoint inhibitors in the clinic, starting with anti-CTLA4 agents, anti-PD1/PD-L1 agents, and approved immunotherapeutic combinations. These chapters cover relevant mechanisms of action, indications, and toxicities seen while combating early, advanced, and metastatic stages in cancer patients. Part II is structured by common and uncommon toxicities that affect major organ sites throughout the body. It begins with a general summary of principles and management options followed by chapters focusing on specific toxicities such as rash and mucosal irritation, muscle and joint toxicity, diarrhea and colitis, pneumonitis, endocrine toxicities, neurological toxicities, cardiac toxicity, renal toxicity, hematologic toxicity, and ocular toxicities. Each chapter provides guidance on how to assess and treat the toxicity and how to support the patient through acute and chronic effects with detailed summary tables for quick reference. Part II concludes with chapters covering management of special patient populations, including patients with autoimmune disease and geriatric patients, treatment and management of fatigue, and a final chapter dedicated to cost effectiveness and the toll of financial toxicity on patients and caregivers. With chapters written by world-recognized leaders in the immuno-oncology field, this text provides thorough coverage of the toxicity and management of adverse effects for immune checkpoint inhibitors. It is an indispensable resource for clinical oncologists, emergency physicians, hospitalists and other medical practitioners in both the hospital and community clinic settings, especially as the use of immune checkpoint inhibitors becomes a fixture in oncology care. Key Features: Outlines strategies for treating high-risk patients facing an acute or chronic side effect to immunotherapy Provides numerous tables that condense and highlight pertinent information for quick reference Describes the various clinical presentations and toxic reactions caused by immunotherapy Purchase includes access to the eBook for use on most mobile devices or computer

Immune Checkpoint Inhibitors in Cancer

Immune Checkpoint Inhibitors in Cancer PDF Author: Fumito Ito
Publisher: Elsevier Health Sciences
ISBN: 0323549500
Category : Medical
Languages : en
Pages : 271

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Book Description
Get a quick, expert overview of the latest clinical information and guidelines for cancer checkpoint inhibitors and their implications for specific types of cancers. This practical title by Drs. Fumito Ito and Marc Ernstoff synthesizes the most up-to-date research and clinical guidance available on immune checkpoint inhibitors and presents this information in a compact, easy-to-digest resource. It's an ideal concise reference for trainee and practicing medical oncologists, as well as those in research. - Discusses the current understanding of how to best harness the immune system against different types of cancer at various stages. - Helps you translate current research and literature into practical information for daily practice. - Presents information logically organized by disease site. - Covers tumor immunology and biology; toxicities associated with immune checkpoint inhibitors; and future outlooks. - Consolidates today's available information on this timely topic into one convenient resource.